MAUDE Adverse Event Report: MAQUET SAS LUCEA; DEVICE, MEDICAL EXAMINATION, AC POWERED

Model Number ARD568604999

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 05/27/2020

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided upon results of investigation.Device not returned to manufacturer.

Event Description

On 27th of may 2020 getinge became aware of an issue with one of our light ¿ lucea.As stated by the torx screw was severed and cupola arm screw¿s hole was stripped.No injury has been reported due to complained situation however we decided to report this issue based on potential as severed screw could led to the lighthead detachment and in the result to injury or contamination.(b)(4).

Manufacturer Narrative

The issue is being investigated by the manufacturing site.

Event Description

Manufacturer's reference number (b)(4).

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

On (b)(6) 2020, getinge became aware of an issue with one of our surgical lights ¿ lucea.As stated, the torx screw was severed and cupola arm screw¿s hole was stripped.No injury has been reported due to complained situation however we decided to report this issue based on potential as severed screw could led to the screw or headlight detachment and in the result to injury or contamination.The device has been identified as a lucea 50 sf.Catalog number is ard568604999 and serial number (b)(6).Manufacturing date is (b)(6) 2013.It was established that when the event occurred, the surgical light did not meet its specification due to the severed screw and stripped screw¿s hole and it contributed to the issue.It is unknown if the device was being used for patient treatment.During the investigation it was found that the reported scenario has never lead, to date, to serious injury or worse.The manufacturer¿s subject matter experts have investigated the issue.Unfortunately, the specific root cause wasn¿t possible to be established due to lack of information that was not possible to be obtained, despite our best efforts.We believe that currently and overall, the related devices are performing correctly in the market with regards to the reported issue.

• Brand Name: LUCEA
• Type of Device: DEVICE, MEDICAL EXAMINATION, AC POWERED
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 10158033
• MDR Text Key: 195259407
• Report Number: 9710055-2020-00179
• Device Sequence Number: 1
• Product Code: KZF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARD568604999
• Device Catalogue Number: ARD568604999
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1